Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant chemotherapy in locally advanced breast cancer: results of the phase II study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023052

Enrollment

Unknown

Registered

2019-05-09

Start date

2017-02-01

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Case series:Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged between 18 and 70 years without previous treatment for this breast cancer; 2. Clinical stage IIB-IIIC, Patients with locally advanced breast cancer who plan to receive neoadjuvant therapy; 3. at least one measurable target lesion; 4. Karnofsky performance score =70 points; 5. Bone marrow function: absolute neutrophil count (ANC)=2.0×10^9/L; platelets=100×10^9/L; hemoglobin =90g/L; 6. Renal functionserum creatinine 44-133 µmol/L; 7. Hepatic functionalanine aminotransferase (ALT) and aspartate aminotransferase(AST) =1.5×ULNserumAlkaline phosphatase =2.5×ULNserum, bilirubin= ULN; 8. All of the patients were required to have a left ventricular ejection fraction (LVEF) >50%; 9. Patients had a life expectancy of 12 months or more; 10. Pregnant women of childbearing age must be negative for pregnancy test; 11. willingness to sign the written informed consent document.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastases; 2. New York Heart Association (NYHA) class =II heart failure; 3. Severe or uncontrolled infection; 4. Known or suspected hypersusceptibility to any agents used in the treatment protocol; 5. The first dose of the study drug was used within 30 days before the administration of the drug, and was treated with radiotherapy or other chemotherapy drugs; 6. Women who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation; 7. The investigator believes that participating in the trial does not meet the best interests of the subject (eg, endangering their health) or any situation that would impede the evaluation of the protocol.

Design outcomes

Primary

Measure	Time frame
pCR rate;	—

Secondary

Measure	Time frame
Objective Response Rate;Rate of Breast conserving surgery;Adverse events;	—

Countries

China

Contacts

Public ContactZhenchuan Song

Fourth Hospital of Hebei Medical University

songzhch@hotmail.com+86 13739745699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026